Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
510(k) Number K920627
Device Name MODEL ELI 100 ELECTROCARDIOGRAPH
Applicant
Mortara Instrument, Inc.
7865 N. 86th St.
Milwaukee,  WI  53224
Applicant Contact JOHN PRIMOZICH
Correspondent
Mortara Instrument, Inc.
7865 N. 86th St.
Milwaukee,  WI  53224
Correspondent Contact JOHN PRIMOZICH
Classification Product Code
LOS
Date Received01/29/1992
Decision Date 09/04/1992
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-